510(k) K965120
K965120 is an FDA 510(k) premarket notification submitted by Dpt Laboratories, Ltd. for the device "ALLCLENZ WOUND CLEANSER". The FDA issued a decision of Substantially Equivalent for Some Indications on Mar 21, 1997. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Dpt Laboratories, Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SN (Substantially Equivalent for Some Indications)
- Decision Date
- Mar 21, 1997
- Date Received
- Dec 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type
- 510(k)